Product code FYC— General, Plastic Surgery
ISOLATION GOWN
- Classification name
- Gown, Isolation, Surgical
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 68
- First cleared
- Most recent
Market context for product code FYC
FDA has cleared devices under product code FYC between 1976 and 2024, filed by 58 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2024
- 2023
- 2022
- 2021
- 2020
- 2018
- 2017
- 2016
- 2001
- 1998
- 1997
- 1996
- 1995
- 1994
- 1993
Top applicants under product code FYC
- American Threshold Industries, Inc.
- American Hospital Supply Corp.
- Medtek Development Corp.
- Kentron Health Care, Inc.
- Hubei Xinxin Non-Woven Co., Ltd.
- Dynatech Medical Products
- Amsco Sterile Recoveries, Inc.
- Yanbian Pacific Textile Co., Ltd.
- Xiamen Probtain Medical Techology Co., Ltd.
- Xiamen Probtain Medical Technology Co., Ltd.
Recent clearances under product code FYC
- K232849 — Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)
- K230135 — Copioumed Chemotherapy Isolation Gown
- K223467 — Disposable Isolation Gown
- K223304 — Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
- K223411 — Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
- K212717 — Paneffort AAMI Level 3 Isolation Gown
- K210414 — CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown
- K214116 — AAMI4 Isolation Gown
- K221027 — Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))
- K220528 — Surgical Isolation Cover Gown
- K213832 — AAMI3 Isolation Gown
- K212422 — Disposable Surgical Isolation Gown
- K210148 — Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120450), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120460)
- K212698 — Plus Medical Isolation Gown Level 3
- K212357 — Surgical isolation gown
- K212633 — Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue
- K211538 — Protect X Level 3 Isolation Gown
- K210785 — Disposable Surgical Gowns
- K212504 — Isolation Gown AAMI Level 3
- K210131 — ComfortGuard Surgical Isolation Gown
- K203415 — Surgical Isolation Gown
- K202310 — Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back
- K190306 — AMD Ritmed AssureWear VersaGown
- K171535 — SURGICAL ISOLATION GOWN
- K160471 — Medline Non-Surgical Isolation Gown-
- K160361 — PRIMAGARD Isolation Gown (AAMI PB70 Level 3)
- K160339 — Cardinal Health Isolation Gown
- K003749 — 100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN
- K982369 — CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS
- K971917 — KENTRON'S ISOLATION GOWN
- K972410 — IMPERVIOUS ISOLATION GOWN
- K971702 — FAR-EAST BARRIER GOWNS
- K970814 — NON-STERILE ISOLATION GOWN
- K960999 — ISOLATION GOWN
- K954549 — SURGICAL APPAREL
- K954747 — NIOMED BARRIER GOWNS
- K952114 — KOOL GARD SINGLES GOWN
- K952115 — BARRIER GOWN, KOOL-GARD BACKLESS GOWN
- K952116 — COVER GOWN
- K942351 — DI ISOLATION GOWN
- K941845 — BUSE STAFF PROTECTION GOWNS AND KITS
- K945223 — OREX ISOLATION GOWN
- K931145 — NON-STERILE ISOLATION GOWN
- K923162 — TBC TRAUMA SUIT PROTECTIVE GOWN
- K922442 — ISOLATION GOWNS
- K930026 — POLY-MED DISPOSABLE PERSONAL PROTECTION KIT
- K925077 — POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS
- K923188 — DYNASTY IMPERVIOUS ISOLATION J-SUIT
- K920404 — SURGEON'S GOWN
- K921058 — DISPOSABLE ISOLATION GOWN
- K922234 — DYNASTY ISOLATION GOWN
- K910410 — SURGICAL GOWNS, EXTRA-LARGE SIZE
- K891677 — COATED ISOLATION GOWN
- K880484 — SURGICAL GARMENTS
- K882281 — GOWN, ISOLATION, SURGICAL (FYC)
- K874888 — ISOLATION GOWN
- K874766 — INTERPRO INT'L, INC. ISOLATION GOWN
- K874318 — MAXIMUM CONTROL GOWN
- K864479 — CARETEX ISOLUTION GOWNS
- K851823 — DISPOSABLE ISOLATION GOWN
- K844786 — NURSES & SURGEONS CAPS, ISOLATION GOWNS-FIRE RETAR
- K840229 — CONTROL COVER GOWN
- K801162 — BARRIER PLUS SURGEON GOWNS
- K801069 — STERILE ISOLATION GOWN
- K780605 — ISOLATION GOWN
- K770488 — ISOLATION GOWN
- K761080 — ISOLATION GOWN PACK
- K760904 — CLEANING AND ISOLATION ROOM KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.